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FDA Open Hearing Transcript, 1974 August 21

 File — Box: MSS 00-04, S3, Box 2

Scope and Contents

From the Series:

This series of U.S. Food and Drug Administration files is comprised of 5 boxes (2.1 linear feet). During 1974 the FDA held several hearings investigating IUDs and septic abortions, and, specifically, the safety of the Dalkon Shield. In preparation for these investigations the agency asked AHR to present documents concerning production of their IUD. The documents the company provided make up part of this series. (Most, if not all of these documents, are also found in the Source Files.) Also included here are transcripts of various hearings. In 1983 the FDA received a request under the Freedom of Information Act to produce documents relating to AHR and the Dalkon Shield. Copies of those documents are also in this series.

Dates

  • Creation: 1974 August 21

Access

The Dalkon Shield Claimants Trust Collection was transferred to the University of Virginia Law Library by order of the U. S. Bankruptcy Court for the Eastern District of Virginia in September 2000. Under that order, Series I through V are open for research with no restrictions. The Court imposed the following access restrictions for the materials in Series VI (the Trust's Central Records Library and Outside Counsel Files):

"5.01 Preservation of Claimants' Privacy. No Identifying Information, or any document or record within the Trust Materials containing Identifying information, relating to any Personal Injury Claimant --- or Other Claimant --- may be disclosed at any time, without written consent of the relevant Personal Injury Claimant or Other Claimant, or an Order by the Court allowing such disclosure."

The Court defined "Identifying Information" as the following:

"Identifying Information" means a person or entity's name, address, telephone number, facsimile number, email address, and any unique identifier including but not limited to a social security number, tax identification number, passport number, and military identification number."

Requests for material in Series VI should be made in advance to allow Special Collections staff time to determine whether it contains identifying information, and to allow for the redaction of such information before permitting access. Copying documents in Series VI may be restricted, and advance consideration of such requests is required.

Extent

From the Collection: 327.5 Linear Feet (408 boxes and cartons, 3 volumes, 271 videotapes, 416 three ring notebooks)

Language of Materials

From the Collection: English

Arrangement

S is Series

Physical Description

2 folders

Repository Details

Part of the Arthur J. Morris Law Library Special Collections Repository

Contact:
Arthur J. Morris Law Library
580 Massie Road
University of Virginia
Charlottesville Virginia 22903 United States